Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Clinical Chemistry Phenobarbital Recalled by Abbott Laboratories, Inc Due to Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent...

Date: November 16, 2012
Company: Abbott Laboratories, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories, Inc directly.

Affected Products

Clinical Chemistry Phenobarbital, list number 1E08

Quantity: 1289

Why Was This Recalled?

Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Laboratories, Inc

Abbott Laboratories, Inc has 31 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report